Well looky here, Bush has done the future of stem cell research a good turn. From today's NYT:
August 18, 2001
Bush's Stem Cell Policy May Streamline
Research
By NICHOLAS WADE
Biologists may find there are fewer
restrictions on research with
embryonic stem cells under the Bush
administration than they would have faced
under the Clinton administration, whose
guidelines have been scrapped, officials at
the White House and the National Institutes
of Health said.
The abolition of the guidelines means that
researchers can now use, among other
sources, the embryonic stem cells first
derived in 1998 by Dr. James A. Thomson
of the University of Wisconsin, which did
not comply with the Clinton administration
guidelines in two technical respects. And the
foundation that handles the university's
patents has said there was nothing in the way of researchers gaining access
to the cells and doing any research they please except for cloning a human or
inserting the cells into other embryos.
Dr. Lana R. Skirboll, director of the Office of Science Policy at the health
institutes, said the guidelines governing embryonic stem cell research would
be replaced by the four conditions specified by President Bush in his Aug. 9
speech: that the cells were derived before that date, that donors gave
informed consent, that the cells must come from excess embryos created
solely for reproductive purposes and that donors were not offered financial
inducement.
Scientists applying for federal grants from the health institutes need only list
which of the approved embryonic cell lines they intend to use, and there will
be no further scrutiny other than the usual review of grants by outside
experts. The agency is developing the registry and will publish it soon on the
Internet, Dr. Skirboll said.
Along with the guidelines, a supervisory panel of the health institutes called
the Human Pluripotent Stem Cell Review Group has been abolished.
"We see a much more streamlined process," Dr. Skirboll said. "Once the
registry is up, if your grant application lists a cell line on the registry, there is
no secondary review."
The guidelines drawn up under the Clinton administration "no longer pertain,"
she said, because the criteria specified by President Bush "capture the
essential elements of the guidelines and supplant them."
The four straightforward principles described by Mr. Bush replace many
pages of federal regulations specifying the conditions under which the cells
must have been obtained. The reason is that with research now confined to
existing cell lines, the guidelines are unnecessary, a White House official said.
The new Council on Bioethics, to be led by Dr. Leon Richard Kass of the
University of Chicago, will provide general ethical guidance, and it will not,
as many scientists had expected, revise the health institutes' guidelines on
stem cell research or draw up new ones of its own. The Kass council "will
not be developing specific regulations," the White House official said.
Dr. Skirboll said the full registry of up to 60 lines of human embryonic stem
lines would be published as soon as permission had been obtained from
those who derived them to use their names.
The 60 lines were all derived independently, from different human embryos,
and are not clones of one another, she said. Some of the derivers have
expressed interest in taking DNA fingerprints of their cells, similar to those
used in forensic cases, to keep track of who is using them. Dr. Skirboll said
that the idea was being considered for that purpose, and not as a method of
policing the Aug. 9 cut-off date.
Though some of the 60 cell lines may prove unsuitable on further study,
researchers should have a much wider choice than many had expected
would be the case.
A second respect in which stem cell research has been made easier is that
the elimination of the agency's guidelines resolves a difficulty faced by the
Wisconsin Alumni Research Foundation, or WARF, which owns the patent
on the human embryonic stem cells derived by Dr. Thomson.
The problem is that Dr. Thomson's cells, which he derived before the
agency's guidelines were written, did not fully comply with the guidelines. The
donor's informed consent was obtained before the embryos were created,
not afterward, as the guidelines required. Also, the guidelines required the
embryos to have been already frozen for storage. Dr. Thomson used
embryos from two sources. One was a United States in vitro fertilization
clinic, in which the embryos were frozen; the other was a clinic in Israel,
which may have supplied fresh embryos. "We could not certify that they
were frozen and Jamie is not in a position to say," said Andrew Cohn, a
spokesman for WARF.
Frozen embryos lose viability over time and fresh embryos would be better
starting material for making embryonic stem cells, which some scientists
speculate may have been one of the several factors behind Dr. Thomson's
success in being the first to establish lines of the cells.
Mr. Cohn said WARF was eager to get its embryonic cell lines into
researchers' hands with minimal restrictions. "We want to push this research
forward as fast as we can," Mr. Cohn said. All distribution of the cells to
academic researchers is handled by WARF, not by the Geron Corporation,
the biotechnology company that holds a major license to the cells.
WARF will make the cells available to academic biologists for a subsidized
fee of $5,000, and they may do whatever research they wish, Mr. Cohn
said.
"Any researcher who gets our cells and makes a patentable discovery will
own that patent," Mr. Cohn said. But, as is routine practice, if researchers
wish to commercialize any discovery they make on the basis of WARF's
patent, they must negotiate a license with WARF, or with Geron for anything
that falls in the scope of Geron's license. Geron financed Dr. Thomson's
research and has commercial rights to six types of human cell that can be
derived from the stem cells.
Mr. Cohn said he was baffled by some researchers' belief that WARF's
conditions on use of the cells turned them into employees of Geron. Geron
would negotiate an agreement in the usual way, he said, and was hardly likely
to block any invention covered by its license.
In the event agreement could not be reached, Geron as licensee had no right
to go to federal court to enforce its patent, Mr. Cohn said. "They have to
come to WARF because we are the patent holder. Who would you rather
have as an arbitrator, a nonprofit, university-affiliated entity or a private
company?"
Biology has made rapid progress over the last quarter century, with several
pioneering discoveries that seemed to place their authors in a monopoly
position, like the recombinant DNA technique for moving genes between
organisms. In that case the patent holders profited without holding
researchers to ransom.
"On broad pioneering-type inventions like these it inevitably works out that
all the stake-holders are satisfied," said Todd Dickinson, a former director of
the United States Patent and Trademark Office. Mr. Dickinson, now at
Howrey Simon Arnold & White, a Washington law firm, said he expected
the same would prove true of embryonic stem cells, without the need for
legislation.
"The system has almost inevitably self-corrected and access to the
technology has been made available. I would expect that WARF would be
fairly likely to take a positive approach to making this technology widely
available," he said, noting WARF's role as the patent portfolio manager of a
leading research university. |
